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NCT00520975

PHASE3

Bevacizumab in Treating Patients With Metastatic Breast Cancer That Overexpresses HER-2/NEU

Sponsor: National Cancer Institute (NCI)

View on ClinicalTrials.gov

Summary

This randomized phase III trial studies first-line chemotherapy and trastuzumab to compare how well they work when given with or without bevacizumab in treating patients with breast cancer that overexpresses human epidermal growth factor receptor 2 (HER-2/NEU) and has spread to other areas of the body. Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Monoclonal antibodies, such as trastuzumab and bevacizumab, may interfere with the ability of tumor cells to grow and spread. Bevacizumab may also stop the growth of breast cancer by blocking the growth of new blood vessels necessary for tumor growth. It is not yet known whether giving first-line chemotherapy together with trastuzumab is more effective with or without bevacizumab in treating patients with metastatic breast cancer that overexpresses HER-2/NEU.

Official title: A Randomized Phase III Double-Blind Placebo-Controlled Trial of First-Line Chemotherapy and Trastuzumab With or Without Bevacizumab for Patients With HER-2/NEU Over-Expressing Metastatic Breast Cancer

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

Start Date

2007-11

Completion Date

2015-10

Last Updated

2026-06-23

Healthy Volunteers

Conditions

Breast Carcinoma Recurrent Breast Carcinoma Stage IV Breast Cancer

Interventions

BIOLOGICAL

Bevacizumab

Given IV

DRUG

Carboplatin

Given IV

DRUG

Paclitaxel

Given IV

OTHER

Placebo

Given IV

BIOLOGICAL

Trastuzumab

Given IV

Inclusion Criteria: * Histologically confirmed breast cancer that overexpresses HER-2/NEU with evidence of metastatic disease and/or chest wall recurrence prior to randomization * HER-2/NEU overexpression is defined as 3+ HER-2 positivity as measured by immunohistochemistry OR HER-2 gene amplification as measured by fluorescent in situ hybridization (FISH, e.g. Vysis), per American Society of Clinical Oncology guidelines * NOTE: representative diagnostic tissue must be submitted for central diagnostic review for confirmation of HER-2/NEU overexpression within two weeks following patient randomization * Evaluable (measurable or non-measurable) disease is allowed if confirmed within 4 weeks prior to randomization * Prior endocrine treatment in the adjuvant or metastatic setting is allowed, provided last dose given \>= 2 weeks prior to randomization * Radiation therapy is allowed provided last dose is given \>= 3 weeks prior to randomization * Adjuvant trastuzumab therapy for breast cancer is allowed provided last dose was given \>= 12 months prior to diagnosis of recurrence * Adjuvant or neoadjuvant taxane therapy for breast cancer is allowed provided last dose was given \>= 12 months prior to diagnosis of recurrence * Adjuvant or neoadjuvant therapy with lapatinib is allowed provided last dose is given \>= 4 weeks prior to diagnosis of recurrence * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 * Absolute neutrophil count \>= 1,000/mm\^3 * Platelet count \>= 100,000/mm\^3 * Total bilirubin =\< 1.5 mg/dL * Aspartate aminotransferase (AST) =\< 2 times upper limit of normal (ULN) (=\< 5 times normal in patients with known liver involvement) * Serum creatinine =\< 1.5 mg/dL * Urine protein: creatinine ratio =\< 0.5 OR 24-hour urine protein \< 1000 mg * International normalized ratio (INR) =\< 1.5 X ULN * Partial thromboplastin time (PTT) =\< 1.5 X ULN * Multi gated acquisition scan (MUGA) scan or echocardiogram (ECHO) within 6 weeks prior to randomization with an left ventricular ejection fraction (LVEF) above the institutional lower limit of normal * Patients must be able to understand and provide signed and dated written informed consent * Major surgical procedure within 4 weeks prior to randomization is not allowed (except for non-operative biopsy, which would not be considered major surgery); treatment can not begin until seven (7) days after placement of a vascular access device * Women must not be pregnant or breastfeeding; all females of childbearing potential must have a blood or urine test within 2 weeks prior to randomization to rule out pregnancy; women of childbearing potential and sexually active males must use an accepted and effective method of contraception * Patients on full-dose anticoagulants (e.g., warfarin) with PT/INR \> 1.5 may be eligible provided that both of the following criteria are met: * The patient has an in-range INR (usually between 2 and 3) on a stable dose of oral anticoagulant or on a stable dose of low molecular weight heparin * The patient has not active bleeding or pathological condition that carries a high risk of bleeding (e.g., tumor involving major vessels or known varices) * Patients with a concurrent active malignancy except carcinoma in situ of the cervix or non-melanoma skin cancers (unless disease-free for at least 5 years at study entry) are not allowed Exclusion Criteria: * Prior chemotherapy, trastuzumab, or bevacizumab for metastatic breast cancer * Patients who have had a cumulative dose of doxorubicin of greater than 360 mg/m\^2 or epirubicin of greater than 640 mg/m\^2 in the adjuvant or neo-adjuvant setting at any time * Patients with grade 2-4 neuropathy * Patients with a history or radiologic evidence of central nervous system (CNS) disease * Patients have a current non-healing wound or fracture * Patients have a hypersensitivity to paclitaxel or drugs using the vehicle Cremophor, Chinese hamster ovary cell products or other recombinant human antibodies * Patients have a serious medical or psychiatric illness that would prevent ability to safely participate or provide informed consent * Patients using any of the following drugs known to inhibit platelet function are not eligible: dipyridamole (Persantine), ticlopidine (Ticlid), clopidogrel (Plavix) and cilostazol (Pletal) * Clinically significant cardiovascular disease, including: * History of cerebrovascular (CVA) within 6 months * Uncontrolled hypertension * Myocardial infarction or unstable angina within 6 months * New York Heart Association class II or greater congestive heart failure, serious cardiac arrhythmia requiring medication, unstable angina pectoris * Clinically significant peripheral vascular disease

Locations (373)

NEA Baptist Memorial Hospital

Jonesboro, Arkansas, United States

East Bay Radiation Oncology Center

Castro Valley, California, United States

Eden Hospital Medical Center

Castro Valley, California, United States

Valley Medical Oncology Consultants-Castro Valley

Castro Valley, California, United States

Bay Area Breast Surgeons Inc

Emeryville, California, United States

Valley Medical Oncology Consultants-Fremont

Fremont, California, United States

Saint Rose Hospital

Hayward, California, United States

Contra Costa Regional Medical Center

Martinez, California, United States

Fremont - Rideout Cancer Center

Marysville, California, United States

Community Hospital of Monterey Peninsula

Monterey, California, United States

El Camino Hospital

Mountain View, California, United States

Highland General Hospital

Oakland, California, United States

Alta Bates Summit Medical Center - Summit Campus

Oakland, California, United States

Bay Area Tumor Institute

Oakland, California, United States

Hematology and Oncology Associates-Oakland

Oakland, California, United States

Tom K Lee Inc

Oakland, California, United States

Valley Care Health System - Pleasanton

Pleasanton, California, United States

Valley Medical Oncology Consultants

Pleasanton, California, United States

Pomona Valley Hospital Medical Center

Pomona, California, United States

University of California Davis Comprehensive Cancer Center

Sacramento, California, United States

Doctors Medical Center- JC Robinson Regional Cancer Center

San Pablo, California, United States

The Medical Center of Aurora

Aurora, Colorado, United States

Boulder Community Hospital

Boulder, Colorado, United States

Penrose-Saint Francis Healthcare

Colorado Springs, Colorado, United States

Porter Adventist Hospital

Denver, Colorado, United States

Exempla Saint Joseph Hospital

Denver, Colorado, United States

Presbyterian - Saint Lukes Medical Center - Health One

Denver, Colorado, United States

Rose Medical Center

Denver, Colorado, United States

Colorado Cancer Research Program NCORP

Denver, Colorado, United States

Swedish Medical Center

Englewood, Colorado, United States

Saint Mary's Hospital and Regional Medical Center

Grand Junction, Colorado, United States

North Colorado Medical Center

Greeley, Colorado, United States

Saint Anthony Hospital

Lakewood, Colorado, United States

Sky Ridge Medical Center

Lone Tree, Colorado, United States

Longmont United Hospital

Longmont, Colorado, United States

McKee Medical Center

Loveland, Colorado, United States

Saint Mary Corwin Medical Center

Pueblo, Colorado, United States

North Suburban Medical Center

Thornton, Colorado, United States

SCL Health Lutheran Medical Center

Wheat Ridge, Colorado, United States

Eastern Connecticut Hematology and Oncology Associates

Norwich, Connecticut, United States

University of Miami Miller School of Medicine-Sylvester Cancer Center

Miami, Florida, United States

Grady Health System

Atlanta, Georgia, United States

Emory University/Winship Cancer Institute

Atlanta, Georgia, United States

Memorial University Medical Center

Savannah, Georgia, United States

Lewis Cancer and Research Pavilion at Saint Joseph's/Candler

Savannah, Georgia, United States

Queen's Medical Center

Honolulu, Hawaii, United States

University of Hawaii Cancer Center

Honolulu, Hawaii, United States

The Cancer Center of Hawaii-Liliha

Honolulu, Hawaii, United States

Portneuf Medical Center

Pocatello, Idaho, United States

Rush - Copley Medical Center

Aurora, Illinois, United States

MacNeal Hospital and Cancer Center

Berwyn, Illinois, United States

Saint Joseph Medical Center

Bloomington, Illinois, United States

Illinois CancerCare-Bloomington

Bloomington, Illinois, United States

Graham Hospital Association

Canton, Illinois, United States

Illinois CancerCare-Canton

Canton, Illinois, United States

Illinois CancerCare-Carthage

Carthage, Illinois, United States

Memorial Hospital

Carthage, Illinois, United States

Hematology and Oncology Associates

Chicago, Illinois, United States

Northwestern University

Chicago, Illinois, United States

John H Stroger Jr Hospital of Cook County

Chicago, Illinois, United States

University of Illinois

Chicago, Illinois, United States

Decatur Memorial Hospital

Decatur, Illinois, United States

Heartland Cancer Research NCORP

Decatur, Illinois, United States

Eureka Hospital

Eureka, Illinois, United States

Illinois CancerCare-Eureka

Eureka, Illinois, United States

NorthShore University HealthSystem-Evanston Hospital

Evanston, Illinois, United States

Galesburg Cottage Hospital

Galesburg, Illinois, United States

Illinois CancerCare Galesburg

Galesburg, Illinois, United States

Illinois CancerCare-Cottage

Galesburg, Illinois, United States

Ingalls Memorial Hospital

Harvey, Illinois, United States

Illinois CancerCare-Havana

Havana, Illinois, United States

Mason District Hospital

Havana, Illinois, United States

Hematology Oncology Associates of Illinois-Highland Park

Highland Park, Illinois, United States

Hinsdale Hematology Oncology Associates Incorporated

Hinsdale, Illinois, United States

Hopedale Medical Complex - Hospital

Hopedale, Illinois, United States

Midwest Center for Hematology Oncology

Joliet, Illinois, United States

Joliet Oncology-Hematology Associates Limited

Joliet, Illinois, United States

Illinois CancerCare-Kewanee Clinic

Kewanee, Illinois, United States

NorthShore Hematology Oncology-Libertyville

Libertyville, Illinois, United States

Illinois CancerCare-Macomb

Macomb, Illinois, United States

Mcdonough District Hospital

Macomb, Illinois, United States

Garneau, Stewart C MD (UIA Investigator)